Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study

Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.

Inclusion Criteria:

1. Consented to join in our project.
2. Adult patients (greater than 18 years old)
3. Patients scheduled for primary unilateral knee arthroplasty

Exclusion Criteria:

1. Patients who refuse to sign the Inform Consent
2. Had an allergy to TXA.
3. Using anticoagulant drugs within a week.
4. Coagulopathy (preoperative platelet count <150,000/mm3,International Sensitivity Index（INR）>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time >1.4 times longer than normal.
5. Breastfeeding
6. Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate<60); or hepatic disfunction(glutamic-pyruvic transaminase>80 or glutamic oxalacetic transaminase>80).Retinopathy (disturbances of color vision).

9.History of thromboembolic disease